DIAgnostic iMaging or Observation in early equivocal appeNDicitis (DIAMOND): open-label, randomized clinical trial.

BACKGROUND: Mild appendicitis may resolve spontaneously. The use of CT may lead to an overdiagnosis of uncomplicated appendicitis. The aims of this study were to examine whether early imaging results in more patients being diagnosed with acute appendicitis than initial observation, and to study the safety and feasibility of score-based observation compared with imaging in patients with equivocal signs of appendicitis. METHODS: Patients with suspected appendicitis with symptoms for fewer than 24 h and an Adult Appendicitis Score of 11-15 were eligible for this trial. After exclusions, patients were randomized openly into two equal-sized groups: imaging and observation. Patients in the imaging group had ultrasound imaging followed by CT when necessary, whereas those in the observation group were reassessed after 6-8 h with repeated scoring and managed accordingly. The primary outcome was the number of patients requiring treatment for acute appendicitis within 30 days. RESULTS: Ninety-three patients were randomized to imaging and 92 to observation; after exclusions, 93 and 88 patients respectively were analysed. In the imaging group, more patients underwent treatment for acute appendicitis than in the observation group: 72 versus 57 per cent (difference 15 (95 per cent c.i. 1 to 29) per cent). This suggests that patients with spontaneously resolving appendicitis were not diagnosed or treated in the observation group. Some 55 per cent of patients in the observation group did not need diagnostic imaging within 30 days after randomization. There was no difference in the number of patients diagnosed with complicated appendicitis (4 versus 2 per cent) or negative appendicectomies (1 versus 1 per cent) in the imaging and observation groups. CONCLUSION: Score-based observation of patients with early equivocal appendicitis results in fewer patients requiring treatment for appendicitis. Registration number: NCT02742402 (http://www.clinicaltrials.gov).

Three-dimensional versus two-dimensional high-definition laparoscopy in transabdominal preperitoneal inguinal hernia repair: a prospective randomized controlled study.

BACKGROUND: Three-dimensional (3D) laparoscopy improves technical efficacy in laboratory environment, but evidence for clinical benefit is lacking. The aim of this study was to determine whether the 3D laparoscopy is beneficial in transabdominal preperitoneal laparoscopic inguinal hernia repair (TAPP). METHOD: In this prospective, single-blinded, single-center, superior randomized trial, patients scheduled for TAPP were randomly allocated to either 3D or two-dimensional (2D) TAPP laparoscopic approaches. Patients were excluded if secondary operation was planned, the risk of conversion was high, or the surgeon had less than five previous 3D laparoscopic procedures. Patients were operated on by 13 residents and 3 attendings. The primary endpoint was operation time. The study was registered in ClinicalTrials.gov (NCT02367573). RESULTS: Total 278 patients were randomized between 5th February 2015 and 23rd October 2017. Median operation time was shorter in the 3D group (56.0 min vs. 68.0 min, p < 0.001). 10 (8%) patients in 3D group and 6 (5%) patients in 2D group had clinically significant complications (Clavien-Dindo 2 or higher) (p = 0.440). Rate of hernia recurrence was similar between groups at 1-year follow-up. In the subgroup analyses, operation time was shorter in 3D laparoscopy among attendings, residents, female surgeons, surgeons with perfect stereovision, surgeons with > 50 3D laparoscopic procedures, surgeons with any experience in TAPP, patients with body mass indices < 30, and bilateral inguinal hernia repairs. CONCLUSION: 3D laparoscopy is beneficial and shortens operation time but does not affect safety or long-term outcomes of TAPP.

Symptomatic Treatment for Uncomplicated Acute Diverticulitis: A Prospective Cohort Study.

BACKGROUND: Even though evidence for nonantibiotic treatment of uncomplicated diverticulitis exists, it has not gained widespread adoption. OBJECTIVE: The aim of this prospective single-arm study was to analyze the safety and efficacy of symptomatic (nonantibiotic) treatment for uncomplicated diverticulitis during a 30-day follow-up period. DESIGN: This study is a single-arm prospective trial (ClinicalTrials.gov ID NCT02219698). SETTINGS: This study was performed at an academic teaching hospital functioning as both a tertiary and secondary care referral center. PATIENTS: Patients, who had CT-verified uncomplicated acute colonic diverticulitis (including diverticulitis with pericolic air), were evaluated for the study. Patients with ongoing antibiotic therapy, immunosuppression, suspicion of peritonitis, organ dysfunction, pregnancy, or other infections requiring antibiotics were excluded. INTERVENTIONS: Symptomatic in- or outpatient treatment consisted of mild analgesics (nonsteroidal anti-inflammatory drug or paracetamol). MAIN OUTCOME MEASURES: The incidence of complicated diverticulitis was the primary outcome. RESULTS: Overall, 161 patients were included in the study, and 153 (95%) completed the 30-day follow-up. Four (3%) of these patients were misdiagnosed (abscess in the initial CT scan). A total of 14 (9%) patients had pericolic air. Altogether, 140 (87%) patients were treated as outpatients, and 4 (3%) of them were admitted to the hospital during the follow-up. None of the patients developed complicated diverticulitis or required surgery, but, 2 days (median) after inclusion, antibiotics were given to 14 (9%, 6 orally, 8 intravenously) patients. LIMITATIONS: This study is limited by the lack of a comparison group and by the relatively short follow-up. CONCLUSIONS: Symptomatic treatment of uncomplicated diverticulitis without antibiotics is safe and effective.

Nonoperative management of perforated diverticulitis with extraluminal air is safe and effective in selected patients.

BACKGROUND: The optimal treatment for diverticulitis with extraluminal air is controversial. OBJECTIVE: The purpose of this research was to evaluate the safety and effectiveness of nonoperative treatment of acute diverticulitis with extraluminal air. DESIGN: This was a retrospective cohort. SETTINGS: The study was conducted at an academic teaching hospital functioning as both a tertiary and secondary care referral center. PATIENTS: All of the patients with CT-diagnosed acute perforated diverticulitis with extraluminal air from 2006 through 2010 were included in this study. INTERVENTIONS: Nonoperative treatment composed of intravenous antibiotics, bowel rest, and percutaneous drainage were the included interventions. MAIN OUTCOME MEASURES: The need for operative management and mortality were measured. RESULTS: A total of 132 patients underwent nonoperative treatment, whereas 48 patients were primarily operated on. Patients treated nonoperatively were divided into 3 groups on the basis of identified factors that independently predicted risk for failure: 1) patients with pericolic air (n = 82) without abscess had a 99% success rate with 0% mortality. 2) Patients with distant intraperitoneal air (n = 29) had a 62% success ratewith 0% mortality. Abundant distant intraperitoneal air and fluid in the fossa Douglas were identified as risk factors for failure. Patients without these risk factors had an 86% success rate with nonoperative management. 3) Patients with distant retroperitoneal air (n = 14) had a 43% success rate with 7% mortality. LIMITATIONS: Comparison of nonoperative versus operative treatment cannot be made because of the study's retrospective nature. CONCLUSIONS: Nonoperative treatment of acute diverticulitis with extraluminal air is safe and effective in patients with a small amount of distant intraperitoneal air or pericolic air without clinical signs of peritonitis.

Impact of hospital volume on failure to rescue for complications requiring reoperation after elective colorectal surgery: multicentre propensity score-matched cohort study.

BACKGROUND: It has previously been reported that there are similar reoperation rates after elective colorectal surgery but higher failure-to-rescue (FTR) rates in low-volume hospitals (LVHs) versus high-volume hospitals (HVHs). This study assessed the effect of hospital volume on reoperation rate and FTR after reoperation following elective colorectal surgery in a matched cohort. METHODS: Population-based retrospective multicentre cohort study of adult patients undergoing reoperation for a complication after an elective, non-centralized colorectal operation between 2006 and 2017 in 11 hospitals. Hospitals were divided into either HVHs (3 hospitals, median ≥126 resections per year) or LVHs (8 hospitals, <126 resections per year). Patients were propensity score-matched (PSM) for baseline characteristics as well as indication and type of elective surgery. Primary outcome was FTR. RESULTS: A total of 6428 and 3020 elective colorectal resections were carried out in HVHs and LVHs, of which 217 (3.4%) and 165 (5.5%) underwent reoperation (P < 0.001), respectively. After PSM, 142 patients undergoing reoperation remained in both HVH and LVH groups for final analyses. FTR rate was 7.7% in HVHs and 10.6% in LVHs (P = 0.410). The median Comprehensive Complication Index was 21.8 in HVHs and 29.6 in LVHs (P = 0.045). There was no difference in median ICU-free days, length of stay, the risk for permanent ostomy or overall survival between the groups. CONCLUSION: The reoperation rate and postoperative complication burden was higher in LVHs with no significant difference in FTR compared with HVHs.

Stoma reversal after Hartmann's procedure for acute diverticulitis.

BACKGROUND: Hartmann's procedure is a treatment option for perforated acute diverticulitis, especially when organ dysfunction(s) are present. Its use has been criticized mostly out of fear of high permanent stoma rate. The aim of this study was to investigate the rate of stoma reversal, reasons behind nonreversal, and safety of reversal surgery. METHODS: This was a single-center retrospective study of patients undergoing urgent Hartmann's procedure due to acute diverticulitis between the years 2006 and 2017 with follow-up until March 2021. RESULTS: A total of 3,319 episodes of diverticulitis in 2,932 patients were screened. The Hartmann's procedure was performed on 218 patients, of whom 157 (72%) had peritonitis (48 (22%) with organ dysfunction). At 2-years, 76 (34.9%) patients had died with stoma, 42 (19.3%) were alive with stoma, and 100 (45.9%) had undergone stoma reversal. The survival of patients with and without reversal were 100% and 42.7% at 1-year, 96.0% and 35.0% at 2-years and 88.9% and 20.7% at 5-years, respectively. The risk factors for nonreversal were old age, a need for outside assistance, low HElsinki Staging for Acute Diverticulitis stage, and higher C-reactive protein level upon hospital admission. The most common reasons for nonreversal in surviving patients were patient not willing to have the operation 18 (41%) and dementia 10 (23%). Twelve (12%) patients had a major complication after reversal (Clavien-Dindo IIIb-IV) and 90-day mortality after reversal was 0%. CONCLUSION: After the Hartmann's procedure for acute diverticulitis, one-third died, half underwent stoma reversal, and one-fifth did not undergo stoma reversal within 2 years. Patients who survive with stoma are either not willing to have reversal or have severe comorbidities excluding elective surgery. The Hartmann's procedure remains a viable option for high-risk patients with perforated acute diverticulitis.

Failure to rescue after reoperation for major complications of elective and emergency colorectal surgery: A population-based multicenter cohort study.

BACKGROUND: As surgical complications inevitably occur, minimizing the failure-to-rescue rate is of paramount interest. Most of the failure-to-rescue research in colorectal surgery has previously focused on elective surgery and anastomotic dehiscence. The aim of this study was to characterize and compare the major postoperative complications demanding reoperation after elective versus emergency colorectal surgery, and to the identify risk factors for failure-to-rescue. METHODS: In this population-based retrospective multicenter cohort study, adult patients undergoing a reoperation for colorectal surgery complication between 2006 and 2017 in 10 hospitals were included. The data were manually extracted. Failure-to-rescue was defined as 90-day mortality after the reoperation. RESULTS: In total, 14,290 patients underwent index colorectal resection, of which 862 (5.8%) underwent emergency reoperation within 30 days (438 [4.3%] after elective, 424 [10.4%] after emergency index operation, P < .001). The failure-to-rescue overall rate was 17.4% (8.0% after elective vs 27.1% after emergency index operation, P < .001). The 4 most common complications were anastomotic dehiscence (36.6%, 316 patients), fascial rupture (23.5%, 203 patients), intra-abdominal bleeding (15.3%, 131 patients), and bowel obstruction (10.2%, 88 patients). The majority (640 patients, 74.2%) had 1 of these complications; 261 patients (30.3%) had multiple complications. In multivariable analyses, the only possibly preventable independent risk factor for failure-to-rescue was perioperative organ failure at the time of reoperation. CONCLUSION: Major complications requiring reoperation occur more than twice as often after emergency surgery and have a higher failure-to-rescue rate of >3× compared with elective surgery. The 4 most common complication types constitute three-fourths of the complications, providing a target for quality improvement.

Thrombin generation in vitro and in vivo, and disturbed tissue factor regulation in patients with acute pancreatitis.

BACKGROUND: Being a central link between inflammation and coagulation, tissue factor (TF) and its inhibitor (TFPI) might be associated with the severity of acute pancreatitis (AP) and the development of organ failure (OF). METHODS: The study comprises 9 severe AP patients with OF and 24 reference patients (11 mild AP and 13 severe AP without OF). Plasma samples were collected on admission. TF-induced thrombin generation in plasma samples was studied using the thrombogram method. In vivo thrombin generation was estimated by prothrombin fragment F1+2. Free and total TFPI levels were measured. To evaluate coagulation status the activated partial thromboplastin time, prothrombin time, platelet count, D-dimer, fibrinogen, antithrombin (AT) 3 and protein C (PC) were determined. RESULTS: There was no significant difference in F1+2 levels between the patient groups. Patients with severe AP tended to show low platelet counts, PC and AT3 levels, and high D-dimer levels. In 11 patients the standard TF stimulation did not trigger thrombin generation in the thrombogram. All deaths occurred in these patients. Free TFPI levels and free/total TFPI ratios were significantly higher in these patients and in non-survivors. CONCLUSION: Failure of TF-initiated thrombin generation in the thrombogram assay explained by high levels of circulating free TFPI may be associated with OF and mortality in AP. and IAP.

Severe hepatic trauma: nonoperative management, definitive repair, or damage control surgery?

BACKGROUND: Management of severe liver injuries has evolved to include the options for nonoperative management and damage control surgery. The present study analyzes the criteria for choosing between nonoperative management and early surgery, and definitive repair versus damage control strategy during early surgery. METHODS: In a retrospective analysis of 144 patients with severe (AAST grade III-V) liver injuries (94% blunt trauma), early laparotomy was performed in 50 patients. Initial management was nonoperative in 94 blunt trauma patients with 8 failures. Uni- and multivariate analyses were used to calculate predictor odds ratios (OR) with 95% confidence intervals (CI). RESULTS: Factors associated with early laparotomy in blunt trauma included shock on admission, associated grade IV-V splenic injury, grade IV-V head injury, and grade V liver injury. Only shock was an independent predictor (OR, 26.1; 95% CI, 8.9-77.1; P < 0.001). The presence of a grade IV-V splenic injury predicted damage control strategy (OR infinite; P = 0.021). Failed nonoperative management was associated with grade IV-V splenic injury (OR, 14.00; 95% CI, 1.67-117.55), and shock (OR, 6.82; 95% CI, 1.49-31.29). The hospital mortality rate was 15%; 8 of 21 deaths were liver-related. Shock (OR, 9.3; 95% CI, 2.4-35.8; P = 0.001) and severe head injury (OR, 9.25; 95% CI, 3.0-28.9; P = 0.000) were independent predictors for mortality. CONCLUSIONS: In patients with severe liver injury, associated severe splenic injury favors early laparotomy and damage control strategy. Patients who arrive in shock or have an associated severe splenic injury should not be managed nonoperatively. In addition to severe head injury, uncontrollable bleeding from the liver injury is still a major cause of early death.

Staging of acute diverticulitis based on clinical, radiologic, and physiologic parameters.

BACKGROUND: Acute diverticulitis is a broad spectrum of diseases with highly varying mortality and need for surgery. The aim of this study was to create an accurate staging of diverticulitis, which could be used both preoperatively and intraoperatively to predict outcome and guide treatment. METHODS: This was a retrospective study of patients treated for diverticulitis in a secondary and tertiary referral center. Multivariate analysis was performed on several clinical, radiologic, and physiologic parameters to find predictors of mortality, need for surgery, need for intensive care, and length of stay. RESULTS: A total of 631 patients were analyzed. Organ dysfunction, peritonitis, and abscess size greater than 6 cm were identified as independent predictors of poor outcome. Pericolic air or no extraluminal air predicted better outcome. Based on these factors, a five-grade staging was created as follows: Stage 1, uncomplicated diverticulitis; Stage 2, complicated diverticulitis with small abscess (<6 cm); Stage 3, complicated diverticulitis with large abscess (≥6 cm) or distant intraperitoneal or retroperitoneal air; Stage 4, Generalized peritonitis without organ dysfunction; Stage 5, generalized peritonitis with organ dysfunction. Mortality was 0, 1%, 3%, 4%, and 32%; need for surgery was 1%, 5%, 46%, 98%, and 100%; and need for intensive care was 0%, 0%, 8%, 11%, and 50%, in Stages 1 to 5, respectively. New staging showed better predictive ability of outcomes compared with earlier classifications in receiver operating characteristic curve analyses. CONCLUSION: The proposed staging can be used on all patients both preoperatively and intraoperatively. It takes into account organ dysfunction, which has major influence on survival. The new staging may be easily implemented in daily clinical practice and incorporated in clinical trials. LEVEL OF EVIDENCE: Diagnostic study, level II.

Applicability of the Clavien-Dindo classification to emergency surgical procedures: a retrospective cohort study on 444 consecutive patients.

BACKGROUND: Patients undergoing emergency surgery have a high risk for surgical complications and death. The Clavien-Dindo classification has been developed and validated in elective general surgical patients, but has not been validated in emergency surgical patients. The aim of the current study was to evaluate the Clavien-Dindo classification of surgical complications in emergency surgical patients and to study preoperative factors for risk stratification that should be included into a database of surgical complications. METHODS: A cohort of 444 consecutive patients having emergency general surgery during a three-month period was retrospectively analyzed. Surgical complications were classified according to the Clavien-Dindo classification. Preoperative risk factors for complications were studied using logistic regression analysis. RESULTS: Preoperatively 37 (8.3%) patients had organ dysfunctions. Emergency surgical patients required a new definition for Grade IV complications (organ dysfunctions). Only new onset organ dysfunctions or complications that significantly contributed to worsening of pre-operative organ dysfunctions were classified as grade IV complications. Postoperative complications developed in 115 (25.9%) patients, and 14 (3.2%) patients developed grade IV complication. Charlson comorbidity index, preoperative organ dysfunction and the type of surgery predicted postoperative complications. CONCLUSIONS: The Clavien-Dindo classification of surgical complications can be used in emergency surgical patients but preoperative organ dysfunctions should be taken into account when defining postoperative grade IV complications. For risk stratification patients' comorbidities, preoperative organ dysfunctions and the type of surgery should be taken into consideration.